There’s No Place Like Home: The Case for Repatriating the Pharmaceutical Supply Chain
By Paul Dupont and Perry Rearick
This year has turned much of the world on its side as nations, communities, and businesses of all sizes reoriented and, in some cases, transformed themselves to an environment that included an unwelcome guest, COVID-19. Changes have included work-from-home initiatives, virtual tradeshows, cancelled conferences, zoom birthday parties, and travel restrictions. The ways we work, move, and interact with each other may never look the same.
Reacting to unexpected challenges by optimistically searching for the opportunities is something we all like to claim, but these challenges have been epic at times. We do not intend to diminish the pain the pandemic has beset on so many. However, the best way to honor the lives of those lost to COVID-19 is to find triumph in the tragedy of this virus. We think the pandemic has broadcast a loud call for bringing our nation’s pharmaceutical healthcare supply chain back to the United States.
Our Tenuous Drug Supply Chain
Over the past 40 years, a great deal of US-based consumer and industrial manufacturing was off-shored to regions of the globe where the cost of production was much less. Reducing production costs was intended to sustain profit margins while keeping prices relatively low for consumers. The pharmaceutical industry was no different.
Not only was pharmaceutical manufacturing being outsourced to companies and facilities outside the US, lab instruments, manufacturing equipment, ingredients, and packaging were being provided by facilities across the globe. Over time the global pharmaceutical supply chain became increasingly complex and more tenuous. It might be described as a spider’s web stretched across a wooded trail, sagging under the weight of a morning dew. When the pandemic struck, it arrived like a lost hiker frantically sprinting through the forest seeking safety and crashing through it.
This is causing the US-based pharmaceutical industry to pause and assess the reliability of its supply chain, and what they discovered was not comforting, but it spurred a desire to strengthen the supply chain that millions of patients rely on.
The Benefits of Bringing it Home
While pharmaceutical supply chains were stretched across the globe over the past 4 decades, regulatory authorities remained national entities. Yes, there are strong global relationships that are intended to promote regulatory and quality standards, like FDA and EMA, but there isn’t a single global regulatory body. This creates natural irregularities in quality and negatively impacts the reliability of drug supplies.
Contracting the supply chain back into the US places it all under a single nation regulatory body, the FDA, considered one of the finest oversight authorities in the world. Imagine if the same investigative organization had inspection authority over not only the production of a finished drug product, but also manufacturing of the raw ingredients. Drug product quality would be much more reliable.
The outcome of all pharmaceutical development and manufacturing is to deliver more effective therapeutics faster to patients. Access to medications without interruption is fundamental to a healthy society and patient health benefits of repatriating drug manufacturing to the US are difficult to overstate.
First and foremost, access and availability of critical medications would improve as supply chains are simplified, transit times reduced, and customs barriers eliminated. Simply avoiding drug shortages whether during a pandemic or during more usual times would lead to more patients receiving the medications they need when they need them.
When facing a public health crisis like the current pandemic, drug supply chains that are entirely, or mostly, domestic, become much more agile. National public health authorities are better able to communicate priorities to those manufacturers and distributors that can act quickly, deliver needed medical care, and reduce suffering.
Economic and Workforce Benefits
The pharmaceutical industry has been a favorite punching bag among those in our society accustomed to using sound bites as attention getters. The reality is that pharma development and manufacturing, along with their supply partnerships is good business. According to the US Department of Commerce, the biopharmaceutical industry already employs 800,000 directly and another 4million indirectly in the US. These are well-paying jobs, many of them requiring advanced degrees. Most of the world’s biopharma research and development comes from the US, and the industry contributes $1.3trillion in economic output. Bringing more of this supply chain back to US soil will add significantly to the economic health of our nation.
According to the Harvard Business Review, 9 out of 10 US workers desire more meaning from their careers, and place that desire ahead of money. Yet, most employers struggle to deliver the labor force’s longing to be part of something that matters to society. For the pharmaceutical industry, that sense of a greater calling comes built in. We have met thousands of people from the pharmaceutical industry and the vast majority are centered on a calling to help those who are suffering from sickness and disease.
When entering the headquarters of Pfizer, workers must navigate a hallway lined with photographs of patients who are alive and suffering less because they have been treated by a drug therapy developed by the pharma company. The cynical may scoff at this, but we know that this is not a workforce that needs a monetary bonus to wake-up early and work long hours.
The Path to Domestic Pharmaceutical Manufacturing
Repatriating our pharmaceutical supply chain will not be accomplished easily or quickly. It will require the cooperation of drug developers, contract development and manufacturing organizations, suppliers, distributors, healthcare providers, regulatory bodies, and our nation’s legislators and executive branch working together. This is a tall order, but the health of our society deserves effective medicines delivered reliably.
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their client’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!
ABOUT THE AUTHORS
Paul Dupont and Perry Rearick
Paul Dupont believes that when businesses strategically align operations, marketing, and sales with actionable guidance from executive leadership, they will experience significantly more growth than their competitors.
Paul is a visionary leader with 25 years’ experience leading commercial operations in life sciences companies that offer complex technical solutions to solve their clients’ biggest challenges. His expertise includes strategic planning, new product development, implementing new business initiatives, guiding marketing activities to include direct and digital methods, optimizing sales operations, and creating remarkable customer experiences. Paul uses an outcomes-driven marketing strategy that delivers immediate and continuous long-term return on investment.
Paul currently serves as the head of digital marketing at Pharmaceutics International, a US-based pharmaceutical contract and development and manufacturing organization (CDMO).
Perry Rearick is the owner of Mungadai Consulting and Marketing Co. He believes that whether seeking to attract the right prospects, engage target audiences more deeply, or build trust to overcome buying objections, effective communications intended to help prospects is the catalyst for success.
Prior to starting Mungadai, Perry was the senior director of publishing at Life Science Connect. During that time, the sales force was transformed from one that simply sold advertising space to a team of business development consultants with an expertise in attracting and engaging the right customers at the right time, resulting in extraordinary results.
Perry also served as officer in the United States Army for nearly 30 years in a variety of leadership positions in Special Forces and Public Affairs. His experience spans the world from the Cold War to the Global War on Terror. He calls upon his years of cross-cultural experiences, complex interpersonal relationships, and a deeper than usual understanding of human behavior as he helps businesses solve problems.
Paul and Perry, along with Mary Beth Wilker, owner of Wilker Design serve as the nucleus of the marketing team for Pharmaceutics International, a US-based pharmaceutical CDMO.